Neoadjuvant Immunotherapy in Early Stage Non-small-cell Lung Cancer Presenting as Synchronous Ground-glass Nodules

XiangNing Fu

Status and phase: Completed; Phase 2

Conditions: Multiple Pulmonary Nodules

Treatments: Drug: Tislelizumab Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT04047186

2019CR107

Details and patient eligibility

About

Neoadjuvant Immunotherapy in Early Stage Non-small-cell Lung Cancer Presenting as Synchronous Ground-glass Nodules: a pilot study

Full description

In many cases, non-small-cell lung cancer(NSCLC) manifested as synchronous ground-glass nodules(GGNs) and makes complete surgical resection impossible. At the same time, there is no good solution for the remaining GGNs after resection of the main lesion. Theoretically, pre-operative anti-PD-1 therapy is optimal for promoting anti-tumor immune response on the basis of maximum tumor mutational burden (TMB). In addition, neoadjuvant immunotherapy should have long-term anti-tumor effect even after surgery, because tumor recurrence may cause memory cells activation and differentiation. This is a pilot study to analysis the pathological remission rate of neoadjuvant immunotherapy and adverse events related to the treatment

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• not less than two GGNs on chest CT
• at least one lesion is diagnosed as NSCLC from biopsy pathology
• no contraindication for surgery
• ECOG score of 0 or 1
• no detectable evidence of distant metastasis

Exclusion criteria

• medical history of malignancy
• pregnant or breeding period
• severe organ failure (heart, liver, kidney, and lung)
• high risk of cerebral-cardiovascular evens
• infection out of control
• received or receiving chemo- and radiotherapy
• history of severe reaction due to allergy or hypersensitivity
• severe mental disorder
• currently been enrolled in other trials
• autoimmune or chronic inflammatory disease

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

neoadjuvant PD-1 group

Experimental group

Description:

receiving neoadjuvant therapy of programmed death-1 (pd-1) immune checkpoint inhibitor

Treatment:

Drug: Tislelizumab Injection